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We are seeking a highly organized and detail-oriented professional to join our Non-Clinical Development team. This individual will provide operational and administrative support across all aspects of non-clinical development, ensuring smooth execution of studies and team deliverables. The role is cross-functional, requiring close collaboration with internal stakeholders (finance, legal, program management, research teams) and external vendors/CROs. The successful candidate will be proactive, resourceful, and comfortable managing multiple priorities in a fast-paced environment.
Job Responsibility:
Maintain and monitor non-clinical study timelines, proactively flagging risks or delays to relevant stakeholders
Provide operational support for DMPK and bioanalytical studies
Manage inventory of critical reagents, internal standards, and other materials for DMPK and bioanalytical needs
Coordinate ordering of necessary study materials in collaboration with procurement
Liaise with study directors and CROs to support project execution
Track study milestones and deliverables for internal reporting and management
Support the drafting, review, and execution of contracts, work orders, and amendments with CROs and external partners
Act as the primary liaison between the non-clinical team, legal, and procurement to facilitate timely contract execution
Maintain vendor relationship tracking and ensure CRO compliance with company policies
Work with US and internationally based CROs in the conduct of nonclinical studies
Prepare and submit purchase order (PO) requests for non-clinical activities
Track invoices and ensure timely payment in coordination with the finance department
Support budget tracking and forecasting for all non-clinical studies
Effectively engage with the Finance department to maintain alignment with Non-Clinical Development budget forecasting and maintenance
Serve as a central point of contact for operational needs of the non-clinical development team
Support the preparation of team presentations, reports, and trackers
Organize team meetings, take minutes, and ensure timely follow-up on action items
Assist with regulatory and submission readiness activities as needed
Requirements:
6+ years of experience in pharmaceutical/biotech operations, nonclinical development, or project coordination
Demonstrated strong organizational skills with the ability to effectively manage multiple tasks and competing priorities simultaneously
Excellent verbal and written communication and interpersonal skills, with the ability to work effectively with cross-functional teams and external vendors
Familiarity with contracts, budgets, and financial systems (e.g., invoice tracking, purchase orders, etc.)
Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word)
Bachelor’s degree with 6+ years of relevant experience, or an advanced degree (MS) with experience in Toxicology, Pharmacology, or a related discipline
Nice to have:
Experience with project management tools is a plus
Knowledge of GLP and the overall drug development process is strongly preferred